Lariat Loop Applicator
FDA 510(k) K060721 · Sentreheart
510(k) numberK060721
Submission
- Device name
- Lariat Loop Applicator
- Applicant
- Sentreheart
Palo Alto, CA, US - Received
- March 17, 2006
- Decision date
- June 2, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAT – Suture, Nonabsorbable, Synthetic, Polyethylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5000
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253910 | Stitch - Suture Wires and TapesGAT · Traditional | GM Dos Reis Industria e Comercio Ltda. | 08/22/2026SE |
| K261021 | EasyWhip FamilyGAT · Traditional | Winter Innovations, Inc. | 07/01/2026SE |
| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTapeGAT · Traditional | Teleflex Medical, LLC | 05/06/2026SE |
| K254275 | HyperSuture All Green Extension LineGAT · Traditional | Threadstone, LLC | 03/23/2026SE |
| K254188 | Meniscus VersaflexGAT · Traditional | GM Dos Reis Industria e Comercio Ltda. | 02/19/2026SE |
| K253145 | Pre-Sutured TendonGAT · Special | Rti Surgical, Inc. | 10/22/2025SE |
| K253024 | ProZip Knotless ImplantGAT · Special | Riverpoint Medical | 10/16/2025SE |
| K252225 | PowerKnot High Strength SuturesGAT · Traditional | Medacta International S.A. | 09/12/2025SE |
| K252201 | HS FiberGAT · Special | Riverpoint Medical | 08/13/2025SE |
| K242201 | HyperSuture White/Green Extension LineGAT · Traditional | Threadstone, LLC | 03/27/2025SE |
More from Threadstone, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K153096 | LARIAT RS Suture Delivery DeviceGAT · Special | 11/25/2015SE |
| K142241 | LARIAT sulture Delivery DeviceGAT · Special | 09/12/2014SE |
| K090385 | Lariat II Suture Delivery DeviceGAT · Traditional | 05/06/2009SE |
| K080364 | Findrwirz Guide Wire SystemDQX · Traditional | 08/11/2008SE |
| K070126 | Occlusion Balloon CatheterDQY · Traditional | 02/08/2008SE |
Questions and answers
When was Lariat Loop Applicator cleared by the FDA?
Lariat Loop Applicator (K060721) received a 510(k) decision of Substantially Equivalent on June 2, 2006, 77 days after the submission was received.
What is the product code of K060721?
The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.